In the United States, pharmaceutical wholesalers and retailers with a valid license from the Drug Enforcement Agency (DEA) can legally possess and distribute products that fall under Schedule II through Schedule V on the DEA's schedule of controlled substances. However, stakeholders in the pharmaceutical supply chain have experienced increasing interruptions in operations due to DEA investigations and related actions because of concerns regarding illicit use of controlled substances.
In the case of wholesalers, DEA claims may be based on wholesalers filling orders from customers who, according to the DEA and possibly unbeknownst to the wholesaler, were knowingly or unknowingly allowing illicit use of controlled products. The DEA expects wholesalers to detect and reject orders that are not for legitimate use (even if the pharmacy ordering the product has a valid DEA license to purchase the products). However, wholesalers may not have insight into their customers' total purchase volumes or their business practices and what they ultimately do with the received controlled product(s) or what is driving the demand for the product(s).
In the case of retailers, individual retail outlets may not have insight into how their sales volume of a controlled substance compares to the sales volume of nearby competitor retail outlets and thereby not know what is or is not abnormal quantities being dispensed. Moreover, when a retail outlet experiences abnormal sales volume of a controlled substance, the retail outlet may not have insight into the possible prescriber(s) and/or patient (i.e., customer) abuse that may be the cause of the abnormal volume. For example, retailers may not be aware of customer purchases made in other locations and therefore would not be aware of identical products purchased, or products purchased that could be used in combination for non-medicinal effects.
In the case of prescribers, individual prescribers may not have insight into how their use of controlled substances compares to prescribing habits of other prescribers in a similar specialty/profession and a similar geography. Moreover, a prescriber may not have insight into patients who are visiting multiple prescribers (“doctor shopping”) and receiving prescriptions for identical products or other products that can be used in combination for non-medicinal effects. Additionally, prescribers may not be aware that their information is being used (through, for example, forgery or duplicated prescriptions) to fill prescriptions unbeknownst to them.